Biocidal Products Regulations (Northern Ireland) 2001

• “stand-by vessel” means a vessel which is ready to give assistance in the event of an emergency on or near an offshore installation;

• “vessel” includes a hovercraft and any floating structure which is capable of being staffed.

• (2) For the purposes of this Schedule, any structures and devices on top of a well shall be treated as forming part of the well.

• (3) For the purposes of this Schedule, a person shall be deemed to be engaged in diving operations throughout any period from the time when he commences to prepare for diving until the time when—

• (a) he is no longer subjected to raised pressure;

• (b) he has normal inert gas partial pressure in his tissues; and

• (c) if he entered the water, he has left it,

and diving operations include the activity of any person in connection with the health and safety of a person who is, or is deemed to be engaged in diving operations.

• (4) Any reference in this Schedule to premises and activities (howsoever described) shall include a reference to any person, article or substance on those premises or engaged in or, as the case may be, used or for use in connection with any such activity, but does not include a reference to an aircraft which is airborne.

Offshore installations

2

• (1) Any offshore installation and any activity on it.

• (2) Any activity, including diving operations, in connection with an offshore installation, or any activity which is immediately preparatory thereto, whether carried on from the installation itself, on or from a vessel or in any other manner, other than—

• (a) transporting, towing or navigating the installation; and

• (b) any activity on or from a vessel being used as a stand-by vessel.

• (3) Diving operations involving the survey and preparation of the sea bed for an offshore installation.

• (4) Subject to sub-paragraph (5), in this Schedule “offshore installation” means a structure which is, or is to be, or has been, used while standing or stationed in water, or on the foreshore or other land intermittently covered with water—

• (a) for the exploitation, or exploration with a view to exploitation, of mineral resources by means of a well;

• (b) for the storage of gas in or under the shore or bed of any water or the recovery of gas so stored;

• (c) for the conveyance of things by means of a pipe; or

• (d) mainly for the provision of accommodation for persons who work on or from a structure falling within any of the provisions of this sub-paragraph,

and which is not an excepted structure.

• (5) For the purposes of sub-paragraph (4), the excepted structures are—

• (a) a structure which is connected with dry land by a permanent structure providing access at all times and for all purposes;

• (b) a well;

• (c) a structure which has ceased to be used for any of the purposes specified in sub-paragraph (4) and has since been used for a purpose not so specified;

• (d) a mobile structure which has been taken out of use and is not for the time being intended to be used for any of the purposes specified in sub-paragraph (4); and

• (e) any part of a pipeline.

Wells

3

• (1) Subject to sub-paragraph (2)—

• (a) a well and any activity in connection with it; and

• (b) an activity which is immediately preparatory to any activity in head (a).

• (2) Sub-paragraph (1) includes keeping a vessel on station for the purpose of working on a well but otherwise does not include navigation or an activity connected with navigation.

Pipelines

4

• (1) Any pipeline.

• (2) Any pipeline works.

• (3) The following activities in connection with pipeline works—

• (a) the loading, unloading, fuelling or provisioning of a vessel;

• (b) the loading, unloading, fuelling, repair and maintenance of an aircraft on a vessel,

being in either case a vessel which is engaged in pipeline works.

• (4) In this paragraph—

• “pipeline” means a pipe or system of pipes for the conveyance of any thing, together with— any apparatus for inducing or facilitating the flow of any thing through, or through a part of, the pipe or system; any apparatus for treating or cooling any thing which is to flow through, or through part of, the pipe or system; valves, valve chambers and similar works which are annexed to, or incorporated in the course of, the pipe or system; apparatus for supplying energy for the operation of any such apparatus or works as are mentioned in paragraphs (a) to (c); apparatus for the transmission of information for the operation of the pipe or system; apparatus for the cathodic protection of the pipe or system; and structure used or to be used solely for the support of a part of the pipe or system, but not including a pipeline of which no initial or terminal point is situated in the United Kingdom or within territorial waters, United Kingdom territorial waters adjacent to Great Britain or a designated area;

• “pipeline works” means— assembling or placing a pipeline or length of pipeline including the provision of internal or external protection for it; inspecting, testing, maintaining, adjusting, repairing, altering or renewing a pipeline or length of pipeline; changing the position of or dismantling or removing a pipeline or length of pipeline; opening the bed of the sea for the purposes of the works mentioned in paragraphs (a) to (c), and tunnelling or boring for those purposes; any activities incidental to the activities described in paragraphs (a) to (d); diving operations in connection with any of the works mentioned in paragraphs (a) to (e) or for the purpose of determining whether a place is suitable as part of the site of a proposed pipeline and the carrying out of surveying operations for settling the route of a proposed pipeline.

Mines

5

• (1) The working of a mine, and work for the purpose of or in connection with the working of any part of a mine.

• (2) In this paragraph “mine” and “working of a mine” have the same meaning as in the Mines Act (Northern Ireland) 1969[^f00048].

Other activities

6

• (1) Subject to sub-paragraph (2)—

• (a) the construction, reconstruction, alteration, repair, maintenance, cleaning, demolition and dismantling of any building or other structure not being a vessel, or any preparation for any such activity;

• (b) the loading, unloading, fuelling or provisioning of a vessel;

• (c) diving operations;

• (d) the construction, reconstruction, finishing, refitting, repair, maintenance, cleaning or breaking up of a vessel except when carried out by the master or any officer or member of the crew of that vessel; and

• (e) the maintaining on a station of a vessel which would be an offshore installation were it not a structure to which paragraph 2(5)(d) relates.

• (2) Sub-paragraph (1) shall not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.

Signed

Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on 5th December 2001.

Michael J. Bohill — A senior officer of the — Department of Enterprise, Trade and Investment

Explanatory note

(This note is not part of the Regulations.)

1 These Regulations have effect with a view, first, to enabling applications to be made for agreement at Community level that an active substance can be used in a biocidal product and, secondly, to authorising the placing on the market and use of biocidal products to which these Regulations apply.

2 These Regulations— i with the exception of regulation 42(2), implement as regards Northern Ireland Directive 98/8 of the European Parliament and the Council of 16th February 1998 concerning the placing of biocidal products on the market (O.J. No. L123, 24.4.98) (“the BP Directive”); and, ii by regulation 42(2), implement as regards Northern Ireland Commission Directive 2000/21/EC (O.J. No. L103, 28.4.2000, p. 70) concerning the list of Community legislation referred to in the fifth indent of article 13(1) of Council Directive 67/548/EEC (O.J. No. 196, 16.8.1967, p. 1) (O.J./SE 1967 p. 234) (“the 2000 Directive”). Schedule 1 to these Regulations is based on Annex V of the BP Directive. The principal provisions are as follows.

3 These Regulations do not apply to certain biocidal products nor to the carriage of biocidal products by rail, road, inland waterway, sea or air (regulation 3 and Schedule 2).

4 A person shall not place on the market a new active substance for use in a biocidal product unless an application to the Health and Safety Executive for Northern Ireland (“the Executive”) or (under the Great Britain Regulations) to the Ministers, or to a competent authority of a member State of the Communities other than the United Kingdom has been made for inclusion of that new active substance in Annex I, IA or IB of the BP Directive. An application to the Executive must be accompanied by dossiers containing information which the Executive must evaluate, following which it must recommend to the European Commission whether or not an active substance should be included in Annex I, IA or IB of the BP Directive (regulations 4, 5 and 6). (The terms “active substance”, “biocidal product”, “competent authority”, “the Executive”, “the Great Britain Regulations”, “the Ministers”, “new active substance” and “place on the market” are defined in regulation 2(1).

5 A person shall not place on the market or use a biocidal product unless that biocidal product has been authorised in accordance with the provisions of these Regulations or the Great Britain Regulations. Where a biocidal product is a low-risk biocidal product, then a registration is required. Where a biocidal product contains an active substance which is included in Annex IB of the BP Directive then that biocidal product may only be used in a particular manner (regulation 8). (The term “low-risk biocidal product” is defined in regulation 2(1)).

6 To obtain an authorisation or a registration under these Regulations, a person must submit an application to the Executive together with the information specified in the Regulations. The Executive may grant a mutual authorisation or registration where another member State has granted an authorisation or a registration in respect of the same biocidal product and the Executive may also grant provisional authorisations and registrations. An authorisation and a registration may be granted subject to conditions (regulations 9 to 14).

7 The Executive may grant an emergency authorisation where such authorisation appears necessary because of an unforeseen danger (regulation 15).

8 Provision is made for a biocidal product to be placed on the market for use in tests and experiments, including those involving the release into the environment of a biocidal product (regulations 16 and 17).

9 The Executive may revoke an authorisation or a registration in certain circumstances. It may also modify the conditions of use subject to which an authorisation or a registration is granted and review an authorisation or a registration (regulations 19 and 20).

10 Provision is made requiring a person to whom an authorisation or a registration has been granted to notify the Executive of information of which he is aware relating to the biocidal product in question (regulation 21).

11 The Executive may prohibit or restrict the sale or use of a biocidal product if it considers that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment (regulation 22).

12 The Executive shall not make use of information submitted to it under the Regulations except in certain circumstances. A person providing information to the Executive may claim confidentiality in respect of that information if he considers that disclosure might harm his industrial or commercial position (regulations 23, 24 and 26).

13 Provision is made for co-operation between applicants for, and the holders of, authorisations or registrations regarding information relating to biocidal products. Provision is also made for the exchange of information between the Executive and the European Commission and the competent authorities in other member States (regulations 25 and 28).

14 The person responsible for first placing a biocidal product on the market is responsible for providing information to the Poisons Information Service. The information may only be disclosed for the purposes of medical treatment of a person affected by the biocidal product (regulation 29).

15 The Regulations impose obligations concerning the packaging, labelling and advertisement of a biocidal product (regulations 30, 31 and 33).

16 An application for an authorisation or a registration of a biocidal product is to be made by, or on behalf of, the person who first places the biocidal product on the market. An applicant must have a permanent office within the Community and the application must be in English (regulation 34).

17 The Executive must ensure that a file is kept in respect of every application for an authorisation or a registration made under the Regulations (regulation 35).

18 There is a right of appeal for any person aggrieved by certain decisions of the Executive made under the Regulations (regulation 36).

19 Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures (regulations 38, 39 and 41 and Schedules 10, 11 and 13).

20 Regulation 42(2) amends the Notification of New Substances Regulations (Northern Ireland) 1994 (S.R. 1994 No. 6) by amending the disapplication in respect of plant protection products to include pesticides and adding a disapplication in respect of biocidal products, thereby implementing the 2000 Directive.

21 In Great Britain the corresponding Regulations are The Biocidal Products Regulations 2001 (S.I. 2001/880) and the Notification of New Substances (Amendment) Regulations 2001 (S.I. 2001/1055). The Great Britain Health and Safety Executive has prepared a regulatory impact assessment in respect of those Regulations and a copy of that assessment, together with a Northern Ireland supplement prepared by the Health and Safety Executive for Northern Ireland, is held at the offices of that Executive at 83 Ladas Drive, Belfast BT6 9FR from where copies may be obtained.

Footnotes

[^f00001]: Formerly the Department of Economic Development; see S.I. 1999/283 (N.I. 1), Article 3(5)

[^f00002]: S.I. 1981/1536 and S.I. 1999/2788

[^f00003]: 1972 c. 68

[^f00004]: See Article 2(2) of S.I. 1978/1039 (N.I. 9)

[^f00005]: S.I. 1978/1039 (N.I. 9)

[^f00006]: Article 13(1A) was substituted by S.I. 1998/2795 (N.I. 18), Article 4

[^f00007]: Article 46(3) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraphs 8 and 18

[^f00008]: S.R. 1995 No. 60, amended by S.R. 1996 No. 376, S.R. 1997 No. 398, S.R. 1998 No. 459, S.R. 1999 No. 150, S.R. 1999 No. 303 and S.R. 2001 No.168

[^f00009]: O.J. No. L123, 24.4.98, p.1

[^f00010]: 1974 c. 37

[^f00011]: S.I. 2001/880

[^f00012]: A copy of the European Inventory of Existing Chemical Substances may be obtained from the European Communities Information Office, 8 Storey’s Gate, London SW1P 3AT

[^f00013]: 1954 c. 33 (N. I.)

[^f00014]: O.J. No. L214, 24.8.93, p. 1

[^f00015]: 1968 c. 67; section 58B was added by the Medicines Act 1968 (Amendment) (No. 2) Regulations 1992 (S.I. 1992/3271)

[^f00016]: S.I. 1994/3142, to which there are amendments not relevant to these Regulations

[^f00017]: S.I. 1994/2987, to which there are amendments not relevant to these Regulations

[^f00018]: S.R. 1995 No. 371, as amended by S.R. 1996 No. 456, S.R. 1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No. 282

[^f00019]: 1985 c. 48, as amended by 1989 c. 27 and 1998 c. 26

[^f00020]: S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469

[^f00021]: S.R. 1993 No. 45, as amended by S.R. 1998 No. 238

[^f00022]: S.R. 1997 No. 269

[^f00023]: S.R. 1994 No. 6, to which there are amendments not relevant to these Regulations

[^f00024]: S.R. 1995 No. 371, as amended by S.R. 1996 No. 456, S.R. 1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No. 282

[^f00025]: S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469

[^f00026]: S.R. 1987 No. 432, as amended by S.R. 1994 No. 174

[^f00027]: S.R. 1992 No. 416, as amended by S.R. 1994 No.270

[^f00028]: S.R. 1992 No. 417, as amended by S.R. 1996 Nos. 48, 49 and 50

[^f00029]: S.I. 1992/3146, amended by S.I. 1995/1671

[^f00030]: S.R. 1993 No. 329

[^f00031]: S.I. 1994/105, to which there are amendments not relevant to these Regulations

[^f00032]: S.I. 1994/3017

[^f00033]: S.I. 1994/3142, to which there are amendments not relevant to these Regulations

[^f00034]: S.I. 1994/3144, to which there are amendments not relevant to these Regulations

[^f00035]: S.R. 1995 No. 201, as amended by S.R. 1995 No. 260, S.R. 1996 No.287 and S.R.1998 No.359

[^f00036]: S.R.1995 No. 371, as amended by S.R. 1996 No. 456, S.R.1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No.282

[^f00037]: S.R. 1995 No. 451, as amended by S.R. 1996 No. 259

[^f00038]: S.R. 1996 No. 50, as amended by S.R. 1997 No. 340 and S.R. 1999 No. 244

[^f00039]: S.I. 1996/2925

[^f00040]: S.I. 1997/322, to which there are amendments not relevant to these Regulations

[^f00041]: S.R. 1998 No. 207, as amended by S.R. 1999 Nos. 83 and 285

[^f00042]: S.I. 1998/1046

[^f00043]: S.I. 1999/1871

[^f00044]: S.R. 1995 No. 60, as amended by S.R. 1996 No. 376, S.R. 1997 No. 398, S.R. 1998 No. 459, S.R. 1999 No. 150, S.R. 1999 No. 303 and S.R. 2001 No. 168

[^f00045]: S.R. 1999 No. 90, as amended by S.R. 2000 No. 375

[^f00046]: S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469

[^f00047]: 1964 c. 29; section 1 was amended by the Oil and Gas (Enterprise) Act 1982 (1982 c. 23), Schedule 3, paragraph 1

[^f00048]: 1969 c. 6 (N.I.)